With today’s growing regulatory bodies and ever-changing requirements, it’s important to have a partner who not only follows the newest guidelines and standards but has the resources to predict what’s coming down the pipeline. AM Life Science is an owner-centric CQV partner with experience in change management and helping sites under consent decree rectify problems with the FDA by knowing what is required by regulatory bodies.

AM Life Science understands CQV execution thoroughly and focuses on forward planning to reduce roadblocks at later stages where things cost more. Utilizing a Validation Lifecycle approach, we author and implement:

  • CQV Master Plans
  • User and Functional Requirement Specifications (URS/FRS)
  • Design Specifications
  • Test Protocols:
  • Commissioning – to protect equipment, validate quality, and ensure seamless execution of qualification protocols
  • Installation Qualification (IQ) – to provide documented assurance that equipment meets and is installed per approved specifications
  • Operational Qualification (OQ) – to provide documented assurance that equipment can function from 0 to 100 percent without damaging itself or nearby components
  • Performance Qualification (PQ) – to provide documented confidence that equipment will perform efficiently and consistently under actual operation conditions
  • Revalidations and Periodic Reviews – to ensure equipment compliance over time
  • Decommissioning – to ensure that equipment is safely and effectively removed from service at the end of its lifecycle
  • Standard Operating Procedures (SOP’s) – to provide written instructions and procedures that are documented clearly so that equipment can be operated in a safe and repeatable manner

In-process or finished-product inspection or testing is not enough to ensure product quality, safety, and effectiveness. The FDA requires process validation or documentation that a specific process will consistently produce a product that meets specifications and quality characteristics.

Process Validation (PV) involves multiple activities spanning the entire lifecycle of the product and process. Our expertise includes authoring and execution of PV documentation:

  • Process Qualification –  Evaluating the process design to determine if it is capable of repeatable commercial manufacture, including facility design, equipment qualification and process performance qualification (PPQ).
  • Continued Process Verification – Ongoing verification that the process produces a product that consistently meets specifications

For services and complete quality assurance, Contact us!